Zofran (Ondansetron) & Birth Defect Risks

While Zofran, and its generic counterparts, work well to treat nausea in cancer and surgical patients, it was never intended – nor approved – to treat morning sickness and nausea in pregnant women.

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Zofran, also known as Zuplenz, was originally developed by GlaxoSmithKline in the 1980s to assist with nausea in cancer patients undergoing treatment. Over the last 20 years, Zofran has become one of the most prescribed anti-nausea drugs, the 20th highest selling brand-name drug in the United States. After GlaxoSmithKline’s patent expired, generic versions were developed by Teva Pharmaceuticals USA and SICOR Pharmaceuticals.

When Zofran Works Well

While Zofran has been beneficial to those patients undergoing chemotherapy, radiation treatment, or as a post-surgical anti-nausea drug, it is important that the medication be prescribed as intended. Zofran is on the World Health Organization’s list of most essential medicines – but not when prescribed off-label.

When Zofran Causes Harm

Risks have started to become apparent for patients given Zofran for off-label uses. Off-label means that a doctor has prescribed the medication to treat conditions for which the FDA has not approved the drug. The only FDA-approved uses of Zofran are the treatment of nausea and vomiting associated with chemotherapy or radiotherapy and prevention of post-surgical nausea.

Common off-label uses of Zofran are pediatric gastroenteritis (stomach flu), rheumatoid arthritis, schizophrenia, and opioid withdrawal. The most frequent off-label prescription is to treat morning sickness in pregnant women. It is this group of patients who are at risk of serious harm from the off-label use of Zofran.

While Zofran, and its generic counterparts, work well to treat nausea in cancer and surgical patients, it was never intended – nor approved – to treat morning sickness and nausea in pregnant women.

Understanding the Health Concern & Risk

A recent study conducted by Danish researchers showed a twofold increase in congenital heart defects associated with the use of Zofran in the first trimester of pregnancy. While other studies have reported mixed data on the safety of Zofran during pregnancy, this study was noteworthy because of the number of pregnancies tracked (almost 900,000) and the timeframe of those case studies (from 1997 – 2010). In addition to the twofold increase in congenital heart defects, the study reported increased incidence of congenital malformation and an overall 30% increased risk of birth defects.

In 2014, a Canadian group analyzed the data in the FDA’s side-effect report database and found cases in which babies born to mothers prescribed Zofran were born with musculoskeletal anomalies, jaundice, heart murmurs, kidney problems, heart defects including atrial septal defect, and low birth weight.

A 2014 Swedish study published in the journal Reproductive Toxicology found “the risks for a cardiovascular defect and notably a cardiac septum defect were increased and statistically significant” when ondansetron was used during pregnancy.

Two of the serious heart defects linked to the use of Zofran are Atrial Septal Defect (ASD) and Ventricular Septal Defect (VSD). ASD is commonly called “hole in the heart” because the defect allows blood to pass between the two upper chambers (or atria) of the heart. Over time, this can result in lung damage from high blood pressure; poor blood oxygen levels; bacterial infections in the heart; and death. VSD is a similar defect found in the lower chambers of the heart.

Other medical research studies have also shown:

  • Twofold increased risk for cleft palate associated with the use of Zofran
  • Potential added risk of cardiac arrhythmias and serotonin syndrome.

The Unfortunate Consequences of Off-Label Prescribing

Because of the off-label prescription of Zofran for nausea during pregnancy, many families and children are now facing lives in which they will continue to suffer from the negative effects of the drug. These medical and emotional challenges may include:

  • Birth Defects
  • Heart Defects / Cardiac Murmurs and Arrhythmia
  • Cleft Palate
  • Kidney Defects
  • Complications During Pregnancy
  • Loss of Life / Death.

Determining Harm

Only after a review of the medical files can it be determined if a child’s health complications were caused by Zofran. The drug injury attorneys of Pogust Braslow & Millrood are leaders in medical litigation and will be glad to consult with you for free, with no obligation. If you are concerned that there may be a link between your child’s medical condition and the use of Zofran, call us today and we can investigate further.

Potential Litigation & Legal Recourse

Medical and legal professionals across the country are currently working together to evaluate the outcomes of relevant research and explore potential legal liability. The evidence suggests potential litigation as a means to secure financial compensation to aid families in providing appropriate healthcare for their children.

About PBM & Our Track Record

Pogust Braslow & Millrood is a plaintiffs’ law firm, where the focus of our work is to protect those who are injured by pharmaceuticals. Our firm was built around litigating pharmaceutical injury cases and representing clients across the country. Our attorneys defend the rights of those who cannot defend themselves against the misdeeds of big business, big pharma, and big healthcare.

We encourage you to review our client testimonials and our resultsincluding jury verdicts in the amount of $72.6 million and $34.3 million.

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